Executive Director, Postmarketing Pharmacovigilance and Compliance

3 weeks ago


Conshohocken PA, United States Madrigal Pharmaceuticals Full time

Reporting to the SVP, Head of Clinical Safety & Postmarketing Pharmacovigilance, the Executive Director, Postmarketing Pharmacovigilance & Compliance will play a key role in management of the Pharmacovigilance System Master File (PSMF), including Compliance and Inspection-readiness activities.  In addition, this role will serve as a mentor and resource for colleagues within the department and will assist as needed in key safety surveillance activities.Position Responsibilities: Provide comprehensive oversight of activities related to PSMF, including tracking of relevant pharmacovigilance processes and activities for compliance purposes, including but not limited to: quality surveillance, review of metrics, institution of any necessary additional monitoring (e.g., Corrective Action and Preventative Actions [CAPAs] and Quality Event deviations, assistance with product incident reviews and coordination of inspection readiness activities.Proactively develop and implement within PV department plans regarding quality, compliance and inspection readiness across Drug Safety & Pharmacovigilance department (both Clinical Safety & Postmarketing Pharmacovigilance)Attend cross-functional Safety Review Team meetings for in-depth product understanding of safety profile of Madrigal products to aid in quality review of pharmacovigilance system and documentsReview and provide PV input for development and tracking of Postmarketing protocols, other relevant Postmarketing Commitments and key safety documents of interestPerform QC review of aggregate safety reports, e.g., Periodic Benefit Risk Evaluation Reports (PBRERs), Risk Management Plans (RMPs) and other safety sections of key documents (including both internal only & regulatory submissions)Support vendor management regarding Qualified Person for Pharmacovigilance (QPPV) activities, including QPPV Project PlanLead development and maintenance of Safety Data Exchange AgreementsProvide subject matter expertise and input for regulatory submissions, e.g., NDA, MAA and regulatory responses, collaborating with cross-functional areas as appropriateQualifications and Skills:Degree in Pharmacy, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV or Clinical Drug Safety MonitoringMinimum 20 years of pharmaceutical industry experience, including a minimum of 15 years of working directly in pharmacovigilance, ideally with experience in both Postmarketing Pharmacovigilance and Clinical SafetyKnowledge of global safety regulations, MedDRA terminology and its application, and principles of data entry and data extraction with global safety databases.  Prior experience entering data and/or reviewing data within system a plusThorough understanding of the drug development process and context applicable to safety surveillance activitiesExperience reviewing cumulative safety data with ability to interpret, synthesize, communicate, and present complex clinical /pharmaceutical informationExperience in the preparation and authoring of pre- and post- aggregate safety reports, RMPs and process documentsAbility to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of viewExcellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing prioritiesExcellent communication skills and ability to influence across multiple functionsCompensation:Base salary is determined by several factors that include, but are not limited to, a successful candidate's qualifications, skills, education, experience, business needs, and market demands. The role may also be eligible for bonus, equity, and comprehensive benefits, which include flexible paid time off (PTO), medical, dental, vision, and life and disability insurance.SummaryLocation: Conshohocken, PA, United StatesType: Full TimeExperience: Senior Manager/SupervisorDepartment: Pharmacovigilance



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